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Fentanyl Transdermal Patch With CHADD™ for Breakthrough Pain in Patients With Moderate to Severe Non-Malignant Pain

NCT00278824 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 109

Last updated 2012-06-05

No results posted yet for this study

Summary

A multi-center study to evaluate the efficacy of CHADD (Controlled Heat-Assisted Drug Delivery) applied over a 50 mcg/hr ZR-02-01 matrix transdermal fentanyl patch for the treatment of breakthrough pain in adult patients with moderate to severe non-malignant chronic pain. The open-label study arm will last up to 12 days. The double-blind arm will last up to 15 days. Eligible patients who complete the open-label arm will be allowed to enroll in the double-blind study arm.

Conditions

Interventions

DRUG

Matrix Transdermal Fentanyl/CHADD Drug Delivery System

Patch applied every 3 days for 15 days

DRUG

Placebo Patch

Placebo patch applied every 3 days for 15 days

Sponsors & Collaborators

  • ZARS Pharma Inc.

    lead INDUSTRY

Principal Investigators

  • Lynn R Webster, MD · Lifetree Clinical Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-01-31
Primary Completion
2006-08-31
Completion
2006-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00278824 on ClinicalTrials.gov